The latest classification guide has been published by the European Commission, which adds many newer device categories. Some clearer and more practical definitions were added, such as of active implantables, depending on where the energy is generated and transmitted to the device, and continuous use, which now includes immediate replacement of one device by another to assure continuity. Tallow was removed from consideration as a material of animal origin.

A landmark decision in the UK courts may produce problems for many device manufacturers who up until now have been deciding the categorisation of their products and, in particular, whether they are medical devices at all. This stems from a decision by the UK Medical Devices Agency to ban a whitening toothpaste, CE-marked in Germany but regarded as a cosmetic in UK. The appeal judges concluded that neither the company nor a notified body could make the decision on whether a product was a medical device or not, only the national court of the country concerned. The end-result is that the company, Optident, withdrew its product Opalescence from the UK market completely, although it is available on all other EU markets as a CE-marked device.

The UK industry is also at odds with the German medical devices association over the problem of private quality marks in addition to the CE mark. Although the UK ABHI is concerned mainly with electromedical devices, the German BVMed, which has condemned private marks, has stated that non-electrical and electrical devices should not be treated differently.

SNITEM, the French trade association, is pressing the Agency for Healthcare Product Safety, to drop or at least modify its plans for additional premarket appraisal of so-called high-risk devices, on the grounds that this negates any Notified Body assessment and CE-marking that might already have taken place. There is also concern that there will be a strong disincentive to innovation. The agency, AFSSAPS, has agreed to consult EUCOMED and other interested parties, before finalising its requirements.

Developers of new biomaterials and devices still have to watch availability of raw materials carefully. Despite the enactment of the Biomaterials Access Assurance Act in USA in Autumn 1998, many suppliers have still not regained confidence in the devices sector, following costly law suits during the 1990s.  Reluctance to supply specialised or small-volume materials is still having an adverse impact on development of new devices. EU-based product developers need to bear this in mind when planning to access the US market.

The saga of single-use disposables continues to run in both the US and the EU. In mid-99, the FDA agreed to prepare a draft proposal for discussion on the topic, in response to widespread concern about the safety of reused devices and unilateral bans imposed by some states or clinical centres. The Medical Device Manufacturers' Association (MDMA) petitioned FDA for a total ban on use of reprocessed single-use devices and has gained support from the Association of Disposable Device Manufacturers. As expected, the American Hospital Association fought any moves to impose requirements to file for 510(k) clearance for reprocessors. The FDA published the results of a study on reused angioplasty catheters, showing many failures in different aspects that might adversely impact outcome following reuse. It was also clear that biopsy forceps, surgical staples and some disposable in vivo monitoring units such as pulse oximetry sensors were widely reused until the point of failure, sometimes during use. The US Senate subsequently voted $1m of the GDA budget further investigation, including pre-market review, enforcement and assessment of reused single-use devices. The amendment to the FDA part of the agencies appropriations (budget) bill was co-authored by Richard Durbin and Edward Kennedy. Senator Durbin had also introduced a bill requiring reprocessors to file 510(k)s if they were processing medium and high risk devices (Class II and III respectively).

The FDA announced in October 1999 that it would not eliminate all reuse, but would focus on high-risk devices where reuse represented a significant safety threat to the patient. It rejected the MDMA's petition but agreed that high-risk devices intended for single-use should not be reused at all. During a public hearing in December 1999, FDA announced that it would require all reprocessors of high-risk devices to comply with applicable pre-market requirements or cease reprocessing them. For medium-risk products, reprocessors would need to register within 6 months and file a 510(k) submission within 2 years. Reprocessors of low-risk devices would be required only to register with FDA. FDA estimated that US hospitals svae a total of $2b per annum by reusing products. Although the US Association of Medical Device Reprocessors saw no need for the FDA's proposed regulatory scheme, the FDA still appears determined to proceed with some kind of tiered approach, though it may be prepared to lengthen times to allow reprocessors to prepare their cases.

In Autumn 1999 the Belgian Government produced legislation that would force manufacturers of single-use devices to show that such devices were positively unsafe for reuse. This proposal has met with almost universal rejection by industry bodies and other EU Member States, from scientific, liability, economic and trade points of view. The main issue is that current law states that the reprocessor or the user of a reprocessed single use device is responsible for continued safety and fitness for purpose, but the Belgian decree would effectively shift burden of proof onto the manufacturer. The European Commission never intended that a label statement of single use should be supported by scientific evidence that repeat use was unsafe, simply that a manufacturer could decide that reuse should not be their responsibility.

The Swedish medical device suppliers' association SLF will hold a conference on the reuse problem in June 2000 (see next conference update for contact details).

Pressure against polyvinylchloride (PVC) also continues, on two grounds, that the plasticisers used (mainly DEHP, one of the phthalates) are toxic to humans, and that disposal of PVC by incineration produces dioxins. There appears to be no evidence that these risks are real - a recent report from the American Council on Science and Health led by the former US Surgeon General Dr Everett Koop gives the plasticisers a clean bill of health, pointing out that removing PVC from devices will put many patients at risk of dying. This is the most recent in a long line of reports and reviews by independent authorities round the world that have concluded there is no evidence for human safety risks from the plasticisers or the PVC itself. Dioxin production during incineration can be minimised by common-sense practices. However, despite this absence of evidence, over 180 US consumer, medical and religious groups have formed a coalition to seek warning labels on PVC products, as a prelude to pressing for a complete ban, and Greenpeace is co-ordinating activities internationally. The coalition bases its concerns about the use of diethylhexyl phthalate on a review of 100 papers published since 1945 carried out by the Lowell Center for Sustainable Production, which has concluded from these that DEHP leaches out of PVC (already known), and has been shown to cause damage to internal organs of rats and monkeys. The report has been attacked by the Health Industry Manufacturers Association as misleading and the European Council for Plasticisers & Intermediates has also rejected its findings.

Universal Health Services, a hospital management company in USA, has responded to anti-PVC pressure by requiring its suppliers to substitute other materials for PVC. Because Baxter Healthcare has stated to the public and its shareholders that it will remove PVC and substitute a material not requiring plasticisers, pressure groups now have a concrete example to hold up against other companies that do not wish to follow this option. Undoubtedly, controversy will continue throughout 2000. In Europe, B Braun Medical has already replaced its PVC fluid bags by polymers not containing di-ethylhexyl phthalate as plasticiser. Despite these trends, a report by Frost & Sullivan projects continued growth of sales of PVC for medical disposables from $94m in 1998 to $136m in 2005. The main competitor will be polyolefin polymers, already used in syringes and increasingly being adapted for other device uses.

Outcomes analysis, procedure review and cost-benefit analyses are becoming more important for medical devices. In Spain, the Agencia de Evaluación de Tecnologías Sanitarias in Andalucia is evaluating hip implantations; the thrust of the study is to work out why there is a lower rate of hip implants in Spain than in other EU countries.

During 1999, there appeared to be progress in enabling the Mutual Recognition Agreement between USA and EU, due for completion within 12 months of its finalisation in December 1998. One target had been to develop a list of FDA-approvable Notified Bodies to act as European Conformity Assessment Bodies. 15 were proposed, from Denmark, France, Germany, Ireland, Italy, the Netherlands, Spain, Sweden and the UK. Several EU-based companies have requested inspections from US authorities. These and other companies will be subjected to continuous evaluation by the EC and the FDA from 2000-2002, during a so-called MRA confidence-building programme, before formal approval. Training sessions were planned for Summer 1999. However, it seems that agreement on some significant areas of both the MRA and the harmonisation of the regulation of devices is at least 12 months away, after it proved impossible to gain consensus on key aspects, amid a climate of disagreement and distrust between the FDA and the EC. Part of the problem is that the FDA is not giving sufficient warning of its audit schedules, and the EC has instructed member states that if they are not given notice so they can schedule attendance at such audits, they are free to ignore the FDA reports.

Japan has agreed to remove requirements for local clinical trials and presentation of data at a Japanese conference or in a Japanese scientific journal. From April 1 2000, GCP-status data should be accepted in support of device approval, no matter where the data was generated. However, the Japanese Ministry of Health and Welfare has announced that it will require considerably more information on the raw material components of medical devices for pre-marketing approval. The US Health Industry Manufacturers' Association is concerned that this will act as a strong disincentive for materials suppliers and may make them stop providing ingredients for devices and biomaterials. The Japanese device sector is said to be positive about the proposals.

During 1999, notified bodies prepared a draft guidance document on evaluation by the notified body assessors of the clinical documentation submitted by applicants for CE marking. This was reviewed in 1999 and the final version issued towards the end of the year. The document outlines data required from applicants and should be read by manufacturers and by those involved in R&D of new devices and biomaterials.

The latest scare to hit UK device manufacturers is that the UK National Institute for Clinical Excellence (NICE) will subject devices to evaluation. After NICE's rejection of GlaxoWellcome's anti-flu drug, it is widely believed that NICE will not act as a facilitator of innovation but as a barrier, based on whether or not the UK's National Health Service is willing or has the budget to pay for a product. The focus of NICE is on cost-effectiveness, which will require economics data to be collected during clinical trials. For medical devices, clinical trials have so far been aimed at demonstrating safety and fitness of purpose in a medical and technical way, not outcomes and health economics. Some members of the devices sector welcome the new focus, because it may encourage assessment of devices on their life-time potential for savings, rather than on their purchase cost compared with conventional treatment. Nevertheless, there is serious concern that high-tech, start-up and small-market companies and products will be seriously disadvantaged by the new system if it is inflexibly applied. The NICE committees are already reviewing hip prostheses and scheduled hearings for hip prostheses and coronary vascular stents for January 27^th 2000. Suppliers were given until November 1^st to prepare product dossiers and, following representations from the Association of British Healthcare Industries, allowed a month's stay of execution so that manufacturers could complete their cases. NICE has sub-contracted the evaluation to the University of Birmingham's Department of Public Health. NICE's next target is deep-cavity woundcare products.

The French government established a Direction de l'Evaluation des Dispositifs Médicaux  during mid-1999. The office contains three unités, dealing with assessment of efficacy, technical standards and vigilance, under the direction of M. Pierre Jallet, president of the current Commission for Medical Device Vigilance. At about the same time, the ban on silicone-containing breast implants was renewed. The US Congress commissioned a study on the health effects of silicone implants from the Institute of Medicine, which exonerated the implants from causing systemic or distant disease or any risk to developing and breast-fed infants, but confirmed the risks of local adverse effects due to leakage and rupture. IOM's review of over 1000 research reports and findings at a 2-day hearing resulted in an opinion that between 20 and 50% of women can expect further treatment to be required in the 3-5 years after implantation. Sometimes this is confined to cleaning and repositioning, but sometimes extensive repair is needed. Researchers at the University of Florida claim that 30% of implants will fail within 5 years and 70% after 17 years, which does not bode well for the estimated 1.5-1.8 million women in USA with such implants.

The standard terms project commissioned by the EC to underpin the EUDAMED medical devices database is delayed, because of the difficulties of creating consonance between US, Japanese. Nordic, ISO and European existing nomenclatures. So far, almost 13,000 terms have been assigned for devices and in vitro diagnostics. These will eventually be used via EUDAMED to describe CE-marked and marketed devices and to standardise terms used for vigilance systems.

The EC issued a Commission Communication 2903-3 at the end of 1999, covering the use of viable human cells and tissues in medical devices. Further draft proposals are expected for live xenogeneic cells, and some movements may be made on blood products for therapeutic use, cell & tissue engineering, tissue banking and organ transplantation, according to Mike Cox of the UK's Medical Devices Agency. All these are areas not covered by Medical Device Directives or the medicinal products legislation, but seen as in great need of a harmonised approach.

During the reorganisation of the European Commission, the devices unit in DGIII (now renamed Entreprise) has lost Joseph Putzeys, the man responsible for overseeing all three device directives, as well as guidelines and drafts relating to use of tissues. Antonio Lacerda will remain. It is still not clear whether responsibility for medical devices will pass from Entreprise to the renamed DGXXIV, SANCO (public health and consumer protection). The Scientific Committee on medical devices and medicinal products will remain as an advisory body on issues of human health and safety under the new regime.

The EU has agreed that device manufacturers can continue to use metric and other measurements on product labelling beyond 1.1.2000. This will allow companies to use labels for both US and European markets.